Evaluation of the Safety and Biologic Effects of an Eicosapentaenoic (EPA)-Enriched Oil (EPA)

June 22, 2011 updated by: Cardiovascular Research Associates
The goal is to test the safety and efficacy of an EPA-enriched oil made by DuPont. DuPont wishes to corroborate the safety of its novel oil rich in EPA in humans prior to placing such a dietary supplement on the market. The goal of this study is to test this oil at doses of 600 mg and 1800 mg of EPA/day as compared to olive oil placebo and a comparator oil providing 600 mg of DHA/day over a 6 wk period. In a parallel arm study design, 120 healthy adults will be randomized to one of four groups (30 in each group) and studied in both the fasting and post-prandial state.

Study Overview

Detailed Description

The safety profile of omega-3 fatty acids is considered to be excellent, and has been recognized as safe (GRAS) by the US Food and Drug Administration when EPA and DHA (docosahexanoic acid) are given together at a dose of 3 grams/day or less. Safety will be monitored by assessing for adverse reactions, measuring vital signs and a variety of laboratory tests including a complete metabolic profile and complete blood count. Efficacy will be assessed by measuring changes in fatty acid profile and or fatty acid ratios.

The goal of this study is to test this EPA oil at doses of 600 mg and 1800 mg of EPA/day as compared to olive oil placebo and a comparator oil providing 600 mg of DHA/day over a 6 wk period. In a parallel arm study design, 120 healthy adults will be randomized to one of four groups (30 in each group) and studied in both the fasting and post-prandial state.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Cardiovascular Research Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy male or surgically sterile females between ages 21-70.
  • BMI of 20-35.

Exclusion Criteria:

  • competitive exerciser.
  • current smokers.
  • those already taking dietary supplements (EPA, DHA, flax seed oil, fish oil, cod liver oil, weight control products, or high doses of vitamin C (> 500 mg/day) or vitamin E (> 400 units/day).
  • those consuming more than 3 oily fish species/week.
  • those consuming > 2 drinks/day.
  • those with a history of a bleeding disorder, or history of significant cardiac, renal, hepatic, gastro-intestinal, pulmonary, neoplastic, biliary or endocrine disorders such as uncontrolled thyroid disease, or uncontrolled hypertension or diabetes.
  • those taking medications affecting serum lipids, body weight, or blood clotting.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Olive Oil
Olive Oil 600 mg/day
600 mg/day for 6 weeks
Other Names:
  • Oleic acid
ACTIVE_COMPARATOR: EPA 1800
1800 mg/day
1800 mg/day for 6 weeks
Other Names:
  • fish oil
  • omega 3 fat
ACTIVE_COMPARATOR: DHA
DHA 600 mg/day
600 mg/day for 6 weeks
Other Names:
  • fish oil
  • omega 3 fat
ACTIVE_COMPARATOR: EPA 600
EPA 600 mg/day
EPA 600 mg/day for 6 weeks
Other Names:
  • fish oil
  • omega 3 fat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
No change in safety laboratory tests including comprehensive metabolic profile and complete blood count.
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy will be assessed by measuring changes in fatty acid profile and or fatty acid ratios.
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Michael L Dansiner, M.D., Cardiovascular Research Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (ACTUAL)

December 1, 2009

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

September 30, 2009

First Submitted That Met QC Criteria

October 1, 2009

First Posted (ESTIMATE)

October 2, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 23, 2011

Last Update Submitted That Met QC Criteria

June 22, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dupont-0609

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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